Preventing Vascular Complications in Type 1 Diabetes: Muscle Metabolic Monitoring

预防1型糖尿病血管并发症：肌肉代谢监测 摘要 使用近红外光谱(NIRS)测量肌肉代谢和血流量 随着销售NIRS设备的公司数量的增加，这一数字逐渐增加。这项技术 表示非侵入性地表征正常和异常肌肉的现在和未来的形态 健康生理学以及常见的致残性疾病，如1型糖尿病(T1D)。有证据表明 对于患有T1D的人来说，健康和功能状态可能与微循环和肌肉受损有关 线粒体功能障碍。此外，运动训练或其他改善症状的治疗方案可能会 使用基于近红外光谱的测量进行评估。然而，目前缺乏商业上可用的 在临床环境中获得这些有价值的测量的选项 冲击力。佐治亚大学运动肌肉生理学实验室的试点数据表明， 临床和研究需求，同时揭示了一个重要的机会 将这项技术商业化。我们的第一阶段提案在评估年轻人方面取得了成功 T1D，为NIRS数据分析程序制作了工作原型，并开发了我们的初始营销 调查。我们的技术能够以非侵入性的方式测量线粒体的功能。 可能被用来确定风险或做出临床决策的人群。为了实现这一目标 临床和商业潜力，需要启动支持来完善设置、执行和 在大范围的基础上分析肌肉新陈代谢和血流量的测量。以肯定其适用性 在第二阶段，我们将应用这项技术来评估老年人 T1D。我们将把我们的发现扩展为商业上可行的产品，对研究和临床都有价值 通过完善我们的骨骼肌近红外光谱测量的自动化分析平台 线粒体容量。我们将简化数据采集，让新手用户能够以低成本获得可靠的数据 以及一致的近红外光谱对肌肉线粒体功能的测量。最后，我们将开发一种 通过a)专注于最适合我们的临床市场的研究进入临床市场的途径 技术和b)采取进入这些市场所需的监管步骤。

Preventing Vascular Complications in Type 1 Diabetes: Muscle Metabolic Monitoring Abstract Measurements of muscle metabolism and blood flow using near infrared spectroscopy (NIRS) have progressively increased, as has the number of companies selling NIRS-based devices. This technology represents the present and future modality for non-invasively characterizing normal and abnormal muscle physiology in health as well as in common, disabling conditions such as Type 1 diabetes (T1D). There is evidence that for people with T1D, health and functional status can be related to impaired microcirculation and muscle mitochondrial dysfunction. In addition, exercise training or other treatment programs to improve symptoms could be evaluated using NIRS-based measurements. Presently, however, there is a lack of commercially available options for obtaining these valuable measurements in clinical settings where they would have the greatest impact. Pilot data from the Exercise Muscle Physiology Lab at the University of Georgia demonstrates both the clinical and research need for this NIRS-based platform, while revealing an important opportunity to commercialize the technology. Our Phase I proposal demonstrated success in evaluating younger adults with T1D, produced working prototypes for the NIRS data analysis program, and developed our initial marketing survey. Our technology is able to yield non-invasively a “vital sign” measure of mitochondrial function in this population that could potentially be used to determine risk or to make a clinical decision. In order to achieve the clinical and commercial potential, start up support is needed to refine processes of setting up, performing, and analyzing measurements of muscle metabolism and blood flow on a wide-scale basis. To affirm the applicability of this technology in a broader, cohort, in Phase II we will apply this technology to evaluate older adults with T1D. We will scale our discoveries into a commercially viable product of value to both the research and clinical communities by refining our automated analysis platform for NIRS-derived measures of skeletal muscle mitochondrial capacity. We will streamline data acquisition such that novice users can at low cost obtain reliable and consistent NIRS-derived measurements of muscle mitochondrial function. Finally, we will develop a pathway for accessing a clinical market by a) focused research on the clinical market best suited for our technology and b) pursuit of the regulatory steps required to access these markets.